Trials / Suspended
SuspendedNCT03990207
The PowerSpiral Antegrade Investigational Device Exemption (IDE) Study
A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Olympus Corporation of the Americas · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate safety and efficacy
Detailed description
The purpose of this study is to evaluate the safety and efficacy of the PowerSpiral™ Enteroscopy System, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PowerSpiral Enteroscopy System | Motorized spiral enteroscopy system |
Timeline
- Start date
- 2022-08-01
- Primary completion
- 2023-06-01
- Completion
- 2023-10-01
- First posted
- 2019-06-18
- Last updated
- 2022-08-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03990207. Inclusion in this directory is not an endorsement.